RISK FACTORS FOR INCOMPLETE TELEHEALTH APPOINTMENTS AMONG PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Introduction: The start of the COVID-19 pandemic in March 2020 led to an increased rate of telehealth visits. Older adults, however, may be more vulnerable to missing appointments given cognitive, physical, and technological gaps. We looked to determine the completion rate of telehealth appointments for older adults with inflammatory bowel disease (IBD), as well as predictors of incomplete appointments. Methods: We conducted a retrospective analysis of all patients with IBD who had at least one telehealth visit at the NYU IBD Center between 3/1/2020-8/31/2021. Only the status of the first telehealth appointment was considered, with an incomplete visit defined as left before being seen, a cancellation or noshow. Medical records were parsed for relevant co-variables, and logistic regression was used to estimate the adjusted association between demographic factors and telehealth appointment completion rates. Results: From 3/1/2020 to 8/31/2021 there were 2,508 patients with inflammatory bowel disease (IBD) who had at least one telehealth appointment, with 1088 (43%) having Crohn's disease (CD), 1037 (41%) having ulcerative colitis (UC), and 383 (15%) with indeterminate colitis (Table 1). Of the 2,508 initial telehealth visits, 519 (21%) were not completed, including 435 (20%) among patients under the age of 60-years as compared to 84 (23%) among patients over the age of 60-years. On multivariable analysis, patients with CD had higher odds of an incomplete appointment as compared to patients with UC (adjOR 1.37, 95%CI 1.10-1.69). Additionally, females had significantly higher odds of an incomplete appointment vs. males (adjOR 1.26, 95%CI 1.04-1.54), and patients who had a non-1st degree relative listed as an emergency contact also had significantly higher odds of an incomplete appointment vs. those with a spouse listed (adjOR 1.69, 95%CI 1.16-2.44;Table 2). Age over 60-years, partnership status, and comorbidities were not associated with appointment completion rates. Among the 361 patients over the age of 60-years who had a telehealth appointment, sex, emergency contact information, IBD subtype, and partnership status were not found to be associated with odds of completing a telehealth appointment. Conclusions: In our study, older patients with IBD were not at higher risk for missed telehealth appointments as compared to younger patients. On multivariable analysis, patients with CD as compared to patients with UC, females as compared to males, and patients who had a non-1st degree relative listed as an emergency contact as compared to those who had a spouse listed were more likely to miss telehealth appointments. Future studies should explore the role of these factors, including the role of social support, in order to design interventions aimed at limiting missed telehealth appointments. (Table Presented) (Table Presented)

FACT OR MYTH: BLACK PATIENTS DO NOT WANT TO PARTICIPATE IN CLINICAL TRIALS

Introduction Underrepresentation of minority groups, particularly Black patients, has been a major issue for most clinical trials. A commonly cited reason is mistrust amongst Black patients due to historical abuse. In a Historically Black College and University (HBCU) at a major metropolitan area with predominant Black patient population, we examined the patient participation rate in a clinical trial compared to other study sites with primarily White patient population. Methods In April 2021, a large prospective, multi-center clinical trial designed to validate a multiomics blood test for early detection of CRC (PREEMPTCRC) was initiated at a HBCU. To optimize study recruitment, culturally-sensitive methods were employed, including racially congruent recruitment staff, and synchronized timing of consent/study procedures with pre-endoscopy COVID testing and clinic visits. Information for all eligible participants screened for the study were recorded and evaluated for a 7- month period (April 1 - October 31, 2021). The enrollment numbers (defined as those consented to the study and had blood samples drawn) for the HBCU and across all other study sites were compared. Demographic and socio-economic data for patients who enrolled and not enrolled at the HBCU were collected to identify potential factors that affect participation. Results During the study period, the number of patients enrolled at the HBCU site (N=229) was significantly higher than the average number enrolled across the other 168 sites (N=90, p<0.0001). In fact, the HBCU site ranked at the top 11th percentile for patient enrollment across all study sites. The main difference between the HBCU site and other study site was race: participants at HBCU were 88.2% Black and 5.2% White, while at the other sites, the participants were 12.0% Black and 71.5% White (p< 0.0001). Comparison of demographic characteristics and socio-demographic data of the enrolled and not-enrolled subjects at the HBCU were similar (Table 1) and did not identify factors that affect participation in clinical trials. Discussion The enrollment of Black patients at a HBCU site was comparable to other study sites in a large prospective, multi-center study of a multiomics blood test for average-risk CRC screening. The findings of our study highlight the importance of providing access to Black patients to clinical trials to ensure adequate representation in research studies. (Table Presented) Table 1. Baseline Patient Demographic and Sociodemographic Information

TM-BERT: A Twitter Modified BERT for Sentiment Analysis on Covid-19 Vaccination Tweets

In transfer learning a model is pre-trained on a large unsupervised dataset and then fine-tuned on domain-specific downstream tasks. BERT is the first true-natured deep bidirectional language model which reads the input from both sides of input to better understand the context of a sentence by solely relying on the Attention mechanism. This study presents a Twitter Modified BERT (TM-BERT) based upon Transformer architecture. It has also developed a new Covid-19 Vaccination Sentiment Analysis Task (CV-SAT) and a COVID-19 unsupervised pre-training dataset containing (70K) tweets. BERT achieved (0.70) and (0.76) accuracy when fine-tuned on CV-SAT, whereas TM-BERT achieved (0.89), a (19%) and (13%) accuracy over BERT. Another enhancement introduced is in terms of time efficiency as BERT takes (64) hours of pre-training while TM-BERT takes only (17) hours and still produces (19%) improvement even after pre-trained on four (4) times fewer data. © 2022 IEEE.

Effect of the Covid-19 Pandemic on Rates of Recurrent Clostridiodes difficile Infection in the Veterans Affairs System

Background. Clostridiodes difficile infection (CDI) is common and classified as an urgent threat by the US Centers for Disease Control and Prevention. Recurrence (rCDI) occurs in 30% of cases and increases with subsequent episodes. As part of a trial of fecal microbiota transplantation vs. placebo for the prevention of rCDI, rCDI is identified using a case-finding algorithm that screens for potential cases across all Veterans Affairs facilities, a key component of which is a stool test confirming the presence of C. difficile. With the emergence of Covid-19 in the Unites States in early 2020, study personnel observed a decreasing number of rCDI cases. We hypothesized that Covid restrictions and fear of transmission prevented patients from coming to a VA facility to submit a confirmatory stool sample, the standard method of diagnosing rCDI. Accordingly, the algorithm was modified to also identify cases where rCDI was empirically treated, without confirmatory testing. Here we report on the prevalence of empiric treatment of rCDI during the Covid pandemic and changes in lab-conformed cases over time. Methods. Cases of potentially rCDI are identified by a weekly query of VA data, using an algorithm that includes laboratory testing results, diagnostic codes, and prescriptions. The ource database is updated daily from every VA facility, encompassing over 8 million Veterans. Potential cases are reviewed by research coordinators using the medical record to determine study eligibility. Beginning June 2020, the algorithm was adjusted to also identify patients with lab confirmation of their first CDI episode but none for their recurrence and identified those who were prescribed treatment for rCDI. Results. We observed a reduction in both the number of weekly cases (22.2 vs. 17.4;P < 0.001) which is a 22% decrease after the Covid-19 emergency declaration (figure). Post-declaration, empiric treatment was prescribed to 159 Veterans (mean, 3.3/week). Potential cases of rCDI/week pre- and post Covid-19 pandemic declaration Conclusion. There was a significant drop in laboratory-confirmed rCDI associated with Covid-19. Recurrent CDI was frequently empirically treated during the Covid-19 pandemic, potentially exposing many patients with non-CDI diarrhea to unnecessary antimicrobial use and its attendant risks.

Prevention of colorectal cancer through multiomics blood testing: The PREEMPT CRC study

Background: The USPSTF recently recommended colorectal cancer (CRC) screening for adults aged 45 to 49 years in addition to those aged 50 to 75 years. This guideline update, which increases the number of screen-eligible individuals by∼19 million, is similar to the recommendation in 2018 by the American Cancer Society (ACS) and is based on the modeling studies that reflect rising CRC incidence rates in younger adults. Currently, only 67% of average-risk individuals over the age of 50 years are up-to-date on CRC screening, and adherence to screening is lower in younger individuals (e.g., 50-54 years). Despite the non-invasive nature of existing stool-based CRC tests, barriers remain to adoption, including a dislike for manipulating stool and a requirement for substantial navigational support. Blood tests may overcome these barriers through ease of sample collection and integration into routine blood work. Methods: Here we describe our prospective, multi-center registrational study for validating a blood-based multiomics test for average-risk CRC screening: PREEMPT CRC. Eligible participants include those aged 45-85 with no known history of CRC or colorectal adenomas who are undergoing CRC screening by colonoscopy. The target enrollment is 25,000 participants, and primary outcome measures are sensitivity for CRC and specificity for advanced colorectal neoplasia, which includes CRC and advanced adenomas. Secondary outcome measures include positive predictive value for CRC, negative predictive value for advanced colorectal neoplasia, and sensitivity for advanced adenomas. Novel recruitment methods have been implemented by combining traditional, site-based recruitment and virtual recruitment using an online web portal, coupled with mobile phlebotomy, to make participation broadly accessible, especially during the COVID19 pandemic. Participants have been enrolled from 40 states as of August 2021, and virtual recruitment has enabled widespread participation, potentially from any zip code in the continental US. To ensure adequate representation of the intended use population, community organizations, federally qualified health centers (FQHCs), and universities have been engaged to reach underserved and minority patient populations. The study was initiated in May 2020 and to our knowledge will be the largest prospective, multi-center registrational validation study of an averagerisk CRC screening test to date.

Covid-19 vaccines: Development, strategies, types and vaccine usage hesitancy

Vaccine development using different platforms is one of the important strategies to address coronavirus disease pandemic. The global need for vaccines requires effective vaccine approaches and collaboration between pharmaceutical and biotechnological companies, governments and the industrial and academic sectors. About 72% of the vaccine candidates are being developed by the private sector, while 28% are carried out by the public sector and different non-profit organizations. COVID-19 vaccines are based on complete viruses (inactivated or attenuated), viral vectors (replicating or not), antigenic subunits (proteins or peptides), nucleic acids (RNA or DNA) or virus-like particles. Important aspects of vaccine development include manufacturing flexibility, speed, cost, safety, cellular and humoral immunogenicity, vaccine stability and cold chain maintenance. Vaccines can be prepared using different manufacturing platforms, computational biology, gene synthesis, structure-based antigen design and protein engineering. Individual confidence, convenience and complacency are factors that affect the attitude towards acceptance of COVID-19 vaccination. This could be complicated by socio-demographic, psychologic, cognitive and cultural factors. © 2021, Finlay Ediciones. All rights reserved.

Assessing occupational noise generated from surgical suction devices vs traditional wall suction in gastrointestinal endoscopy: A quality improvement project

Introduction: Occupational noise exposure can lead to noise-induced hearing loss (NHL) with serious health and economic consequences for workers. The Center for Disease Control and Prevention and the National Institute for Occupational Safety and Health (NIOSH) have published a recommended exposure limit of 85-decibels (dB) for workplace exposure to prevent NHL. Despite these recommendations for workplace noise exposure, little is known about the noise levels generated during gastrointestinal (GI) endoscopy. We aimed to investigate the noise generated by suction during GI endoscopy. Methods: Sound levels were measured using the “NIOSH Sound Level Meter” smart phone application. The noise generated from an adult colonoscope (Olympus HQ190) at various levels of suction were measured using Neptune 3 (Stryker, Kalamazoo, MI) mobile surgical suction device (SSD) that allows a wide range of suction pressure levels versus “traditional” wall suction (WS). Measurements were obtained as average levels over a 30-second interval in a quiet, outpatient ambulatory endoscopy room. Noise measurements were obtained at various positions within the room (endoscopist, nurse/ technician) as well as next to the endoscope suction button. The measurements were obtained with the endoscopist applying no suction, partial suction and complete suction. Results: With the SSD, sound levels increased as suction pressure increased. The highest sound levels were generated when no endoscopic suction was applied. None of the measurements exceeded recommended exposure limits set by the NIOSH (Table 1). With pressure levels set at 200 mmHg (traditional wall suction maximums) sound levels at the endoscopist for SSD and WS were 54.3 dB and 47.1 dB, respectively, e.g. more than 7 times louder. Conclusion: Little is known about the occupational safety of noise levels in endoscopy nor the contribution suction contributes. In this study, noise levels did not exceed the recommended exposure limit set by the NIOSH. However, SSD generates significantly more noise than WS at the same pressure levels. While these levels may not constitute an occupational hazard, they make communication more difficult especially in the COVID era of enhanced PPE (e.g. face shield, N95). The techniques developed during the study offer a simple process that can be implemented in any GI endoscopy suite to assess the contributions of suction to workplace noise..

Enrollment rate of African Americans in a colon cancer screening trial at a historically black college and university is similar to other patient populations

Introduction: Clinical trials often have low enrollment of minorities, particularly African-Americans (AAs), which may limit the generalizability of research findings. Previously identified barriers to AAs recruitment include historical abuses leading to mistrust, communication issues with providers, socio-economic factors, and a lack of access to clinical trials. In a Historically Black College and University (HBCU) serving a primarily AA population at a large safe-net hospital, we evaluated the enrollment of eligible AA patients for a colorectal cancer (CRC) screening clinical trial. This was compared to the enrollment rates across other study sites. Methods: A large, prospective, multi-centered clinical trial to validate a blood-based test for early detection of CRC (PREEMPT-CRC) was initiated at a HBCU, where 84% of patients are AAs. To maximize study recruitment, culturally sensitive methods were employed including racially congruent recruitment staff as well as synchronized timing of consent/study procedures with preendoscopy COVID testing/clinic visits. Detailed information for all eligible subjects was recorded. Demographic and socio-economic data including census information for enrolled and not enrolled subjects were compared. The enrollment rate (defined as enrolled/eligible patients) over the first 6 weeks at the HBCU and that of the other study sites providing screening logs was analyzed. Results: The enrollment rate at the HBCU was 55% (44 out of 80 eligible patients;95% CI 43.5- 66.2%), compared to 49.8% (258 out of 518 eligible patients;95% CI 45.4- 54.2%) at the other 26 study sites. While age and gender of enrolled patients at the HBCU were comparable to other sites, the main difference was race: at the HBCU the study participants were 79.5% AAs and 9.1% whites, while at the other sites the participants were 11.5% AAs and 82.8% whites (p< 0.001). At the HBCU, the demographic characteristics and socio-demographic data including income, marital status insurance status/type, and census tract median household income of the 44 enrolled and 36 notenrolled subjects were similar (Table 1). Conclusion: Contrary to conventional belief that AAs do not want to be involved in clinical trials, we find their enrollment is similar to a predominant white study population when offered the opportunity in a culturally sensitive setting. Future trials should consider including HBCU sites in order to attain adequate AA enrollment to improve the generalizability of research findings. (Table Presented).